Trial Information

Inclusion Criteria:

1. Patients must have histologically or cytologically confirmed adenocarcinoma of the
colon.

2. Patients must have metastatic disease to the liver with at least one lesion that is
measurable by RECIST criteria within 4 weeks prior to entry of study

3. Patients with a history of colon adenocarcinoma treated by surgical resection who
develop radiological or clinical evidence of metastatic cancer do not require
separate histological or cytological confirmation of metastatic disease unless an
interval of > 5 years has elapsed between the primary surgery and the development of
metastatic disease. Clinicians should consider biopsy of lesions to establish
diagnosis of metastatic colon adenocarcinoma if there is substantial clinical
ambiguity regarding the nature or source of apparent metastases.

- Negative for proteinuria based on dip stick reading OR, if documentation of +1
result for protein on dip stick reading, then total urinary protein <= 500 mg
and measured creatinine clearance (CrCl) >= 50 mL/min from a 24-hour urine
collection

7. Life expectancy >= 12 weeks

8. Ability to give written informed consent according to local guidelines

Exclusion Criteria:

1. Patients receiving prior 5-FU for the treatment of metastatic colorectal
adenocarcinoma will be excluded from enrollment. Previous use of 5-FU for adjuvant
treatment of resected stage II or III colorectal adenocarcinoma will be allowed,
provided the time from last 5-FU administration to enrollment is > 3 months.

2. Prior full field radiotherapy <= 4 weeks or limited field radiotherapy <= 2 weeks
prior to enrollment. Patients must have recovered from all therapy-related
toxicities. The site of previous radiotherapy should have evidence of progressive
disease if this is the only site of disease.

3. Prior biologic or immunotherapy <= 2 weeks prior to registration. Patients must have
recovered from all therapy-related toxicities

4. Prior therapy with anti-VEGF agents

5. Patients with a history of another primary malignancy <= 5 years, with the exception
of inactive basal or squamous cell carcinoma of the skin

6. Concurrent use of other investigational agents and patients who have received
investigational drugs <= 4 weeks prior to enrollment.

7. Female patients who are pregnant or breast feeding, or adults of reproductive
potential not employing an effective method of birth control. Barrier contraceptives
must be used throughout the trial in both sexes. Women of childbearing potential must
have a negative serum pregnancy test 48 hours prior to administration of study
treatment.

8. Patients unwilling to or unable to comply with the protocol

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Determine whether[18F]-5-Fluorouracil PET/CT scanning can demonstrate a difference in [18F]-5-Fluorouracil tumor uptake before and after the administration of Avastin

Outcome Time Frame:

1-4 days

Safety Issue:

No

Principal Investigator

Dr Andrew Quon

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Food and Drug Administration

Study ID:

GIIMG0001

NCT ID:

NCT00661154

Start Date:

February 2008

Completion Date:

July 2010

Related Keywords:

Colorectal Neoplasms

Colon Cancer

Rectal Cancer

Anal Cancer

Anus Neoplasms

Neoplasms

Colonic Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Name

Location

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